Effect of Glucocorticoid on Exogenous Insulin Antibody Syndrome

• Status: Not yet recruiting
• Trial end date: 2023-05-20
• Target enrollment: 0
• Participant gender: All

Summary

Diabetic patients who have long-term insulin used can product antibody against exogenous insulin, the investigators named this condition Exogenous insulin antibody syndrome (EIAs). Exogenous insulin antibody can cause blood glucose fluctuation, high blood glucose and refractory hypoglycemia, and have a serious impact on the health of diabetic patients. After adding glucocorticoid, some EIAs patients can reduce insulin dosage, correct hypoglycemia, even eliminate insulin antibody in about half a year, and achieve the goal of blood glucose stability. But up to now, there is no study to evaluate the improvement of blood glucose by glucocorticoid intervention in EIAS patients receiving insulin therapy. This project plans to collect 20 cases of EIAS and carry out a randomized, double-blind, placebo-controlled clinical trial to evaluate the improvement of blood glucose by glucocorticoid intervention.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: chenfengling
• Treatments: Hypoglycemic Agents; Prednisone

Criteria

Inclusion Criteria:

1. The diagnosis of type 2 diabetes was in accordance with the WHO diagnostic criteria of diabetes in 1999:fasting blood glucose ≥ 7.0mmol/l and / or blood glucose ≥ 11.1mmol/l in 2 hours after OGTT

2. Aged between 30-60 years

3. Positive detection of insulin antibody, hyperinsulinemia (refer to WHO standard in 1999, fasting insulin > 15 μ IU / ml or 2h postprandial insulin > 80 μ IU / ml)

4. Type 2 diabetes mellitus patients who receiving insulin therapy

5. Those meeting all the above standards can be included

Exclusion Criteria:

1. Patients who had used animal insulin before the study

2. Type 1 diabetes, gestational diabetes and special type diabetes

3. Diabetic acute complications (ketoacidosis, hyperosmotic nonketotic coma, lactic acidosis) or serious chronic complications ; serious chronic complications (proliferative retinopathy, foot ulcer or gangrene, Complications of heart, brain and kidney)

4. Patients with other serious heart disease, endocrine disease, autoimmune or chronic wasting disease

5. Patients with severe primary diseases such as liver, kidney and hematopoietic system , Patients with psychosis

6. Patients who are using or need to use thiol containing drugs in the near future

7. Patients with severe insulin allergy

8. Glucocorticoid contraindications (severe psychosis and epilepsy, active peptic ulcer or tuberculosis, recent gastrointestinal anastomosis, fracture, wound repair period, corneal ulcer, adrenocortical hyperfunction, severe hypertension, pregnant women, infection beyond the control of antibiotics, such as varicella, mould infection, etc.)